Documents Schenk, Linda 6 results

"We investigated the level of protection of reproductive and developmental toxicity offered through occupational exposure limits (OELs) and Derived No-Effect Levels for workers' inhalation exposure (wDNELs). We compared coverage of substances that have a harmonised classification as reproductive toxicant 1 A or 1B (Repr.1 A/B), numerical values and scientific basis of 12 lists of OELs and wDNELs from REACH Registrants' and the Committee for Risk Assessment. Across the 14 sources of OELs and wDNELs, 53 % of the Repr1A/B-substances had at least one exposure limit (counting groups of metals as one entry). Registrants' wDNELs covered the largest share, 40 %. The numerical values could be highly variable for the same substance across the lists. How often reproductive toxicity is identified as the critical effect varies between the examined lists, both due to different assessments of the same substance and different substance coverage. Reviewing the margin of safety to reproductive toxicity cited in the documents, we found that 15 % of safety margins were lower to reproductive toxicity than the critical effect. To conclude, neither the REACH nor work environment legislation supply wDNELs or OELs for a substantial share of known reproductive toxicants. EU OELs cover among the fewest substances in the range, and in many cases national OELs or wDNELs are set at more conservative levels."

"Occupational exposure limits (OELs) are used as an important regulatory instrument to protect workers' health from adverse effects of chemical exposures. The OELs mirror the outcome of the risk assessment and risk management performed by the standard setting actor. In this study we compared the OELs established by 18 different organisations or national regulatory agencies. The OELs were compared with respect to: (1) what chemicals have been selected and (2) the average level of exposure limits for all chemicals. Our database contains OELs for a total of 1341 substances; of these 25 substances have OELs from all 18 organisations while more than one-third of the substances are only regulated by one organisation. The average level of the exposure limits has declined during the past 10 years for 6 of the 8 organisations in our study for which historical data were available; it has increased for Poland and remained nearly unchanged for Sweden. The average level of OELs differs substantially between organisations; the US OSHA exposure limits are (on average) nearly 40 % higher than those of Poland. The scientific or policy-related motivations for these differences remain to be analysed."

"In the present study we have examined how the European chemicals regulation Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) has influenced occupational risk management of chemicals at Swedish downstream user companies. The data were collected through interviews with occupational health and safety professionals, safety representatives and authority employees. The results show that most of the informants had scarce knowledge about REACH and that REACH implementation has not had any major impacts on downstream users' occupational risk management, but the impacts the regulation has had were perceived as positive. For instance, clear substance identification and increased hazard information were appreciated improvements of safety data sheets (SDS). However, with regards to identifying how to safely use a substance or product neither the SDSs nor the attached exposure scenarios were perceived as sufficient. REACH was not perceived as a major driver for substitution but has had some impact on substitution, either by requiring it for certain substances as through the authorisation procedure or facilitating the identification of relevant substances to substitute as more information on hazards has become available. The obstacles to REACH implementation are similar to those of occupational health and safety legislation; lack of awareness, understanding and/or incentives to take action. Especially smaller companies with their limited resources lag behind. Reaching the full potential of REACH requires more work on motivating and supporting downstream users to fulfil their REACH obligations.'

"Several regulators have recently issued so-called risk-based occupational exposure limits for carcinogenic substances, and also reported estimates of the risk of fatality that exposure to the limit value would give rise to. This practice provides an opportunity to study how differences in the exposure limits set by different regulators are influenced by differences in the scientific judgment (what is the risk at different levels?) and in the policy judgment (how large risks should be accepted?). Based on a broad search, a list was compiled of exposure limits for carcinogens that the respective regulator associates with a numerical risk estimate. For benzene, such data was available from six regulators. The differences in estimates of the risk/exposure relationship and in risk tolerance were about equal in size, while the range for acceptability was somewhat wider. A similar pattern was observed, although less clearly, for substances with data from only two or three regulators. It is concluded that the science factor and the policy factor both contribute to differences in exposure limits for carcinogens. It was not possible to judge which of these two factors has the larger influence."

"It has previously been shown that occupational exposure limits (OELs) for the same substance can vary significantly between different standard-setters. The work presented in this paper identifies the steps in the process towards establishing an OEL and how variations in those processes could account for these differences. This study selects for further scrutiny substances for which the level of OELs vary by a factor of 100, focussing on 45 documents concerning 14 substances from eight standard-setters. Several of the OELs studied were more than 20 years old and based on outdated knowledge. Furthermore, different standard-setters sometimes based their OELs on different sets of data, and data availability alone could not explain all differences in the selection of data sets used by standard-setters. While the interpretation of key studies did not differ significantly in standard-setters' documentations, the evaluations of the key studies' quality did. Also, differences concerning the critical effect coincided with differences in the level of OELs for half of the substances."

"The new European Union (EU) REACH legislation requires derived no-effect levels (DNELs) to be calculated for substances produced in quantities above 10 tonnes/year. Meanwhile, the setting of occupational exposure limits (OELs) continues both at the member state and the EU levels. According to REACH, indicative OEL values (IOELVs) from the Commission may under some circumstances be used as worker-DNELs. On the other hand, worker-DNELs will be derived for several thousand substances, far more than the approximately 100 substances for which IOELVs have been established. Thus, the procedure to set health-based OELs may become influential on that of DNELs and vice versa. In this study, we compare the safety margins of 88 Scientific Committee on OELs (SCOEL) recommendations with those of the corresponding worker-DNELs, derived according to the default approach as described in the REACH guidance document. Overall, the REACH safety margins were approximately six times higher than those derived from the SCOEL documentation but varied widely with REACH/SCOEL safety margin ratios ranging by two orders of magnitude, from 0.3 to 58 (n = 88). The discrepancies may create confusion in terms of legal compliance, risk management, and risk communication. We also found that the REACH guidance document, although encompassing detailed advice on many issues, including default assessment factors for species and route extrapolation, gives little quantitative guidance on when and how to depart from defaults."